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QUATRx PHARMACEUTICALS ANNOUNCES POSITIVE PHASE 3 RESULTS FOR STUDY OF OPHENA (OSPEMIFENE) TO TREAT POSTMENOPAUSAL VAGINAL SYNDROMENovel non-estrogen oral therapy in development for menopausal symptoms [January 3, 2008] ANN ARBOR, MI—QuatRx Pharmaceuticals Company today announced positive results from a pivotal Phase 3 study of
Ophena (ospemifene) to treat postmenopausal women with vulvovaginal atrophy, a common condition associated with menopause.
Top line data show that the multi-center, double-blind, placebo-controlled study successfully met all of its co-primary endpoints. The study was
conducted in 80 U.S. centers and involved more than 800 women. Full results of the study are being submitted to an upcoming scientific
meeting for release later in 2008.
About Postmenopausal Vaginal Syndrome Postmenopausal vaginal syndrome (PVS) is a chronic condition characterized by symptoms including vaginal dryness, sexual pain (dyspareunia), and irritation. Declining estrogen levels during menopause can cause tissues of the vaginal lining to grow thinner and to lose elasticity, a condition known as atrophy. Dryness and irritation associated with reductions in vaginal secretions often cause pain or bleeding during sexual intercourse. The decline in estrogen also contributes to an increase in vaginal pH, creating an environment more susceptible to infection. It is estimated that up to 40% of post-menopausal women have symptoms of PVS. Current prescription treatments approved for this condition all contain estrogen, administered either orally or locally in the vagina. SERMs that are currently approved and marketed in the United States have not been shown to have beneficial effects on vaginal tissue and none are approved for use in treating this condition. About QuatRx QuatRx Pharmaceuticals is focused on the discovery, licensing, development and commercialization of compounds in the endocrine, metabolic and cardiovascular therapeutic areas. In addition to Ophena, QuatRx has three other product candidates in active clinical development and two preclinical development programs. Fispemifene is a new selective estrogen receptor antagonist that is in Phase 2 studies as an oral treatment for the symptoms of secondary hypogonadism in men. QRX-431, a novel, selective thyroid receptor beta agonist, is in Phase 1 studies as a potential treatment for lipid disorders and obesity. Asord (becocalcidiol), a novel Vitamin D analogue, is in Phase 2 clinical trials for the treatment of psoriasis through QuatRx’s partner, CollaGenex Pharmaceuticals, Inc. QuatRx’s two preclinical small molecule programs are designed to address common endocrine disorders in women and men. In Europe, QuatRx operates through its Finnish subsidiary, Hormos Medical Ltd, located in Turku, Finland. For press releases and other Company information, please visit www.quatrx.com.
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© 2008 QuatRx Pharmaceuticals Company Terms of Use |
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